Office of the National Coordinator; American Health Information Community Chronic Care Workgroup Meeting, 24717-24718 [06-3918]
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Federal Register / Vol. 71, No. 80 / Wednesday, April 26, 2006 / Notices
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transition period, the Consent
Agreement requires Abbott and Boston
Scientific to enter into interim
transitional service and confidentiality
agreements.
Finally, Abbott has taken a small
equity position (under 5 percent) in
Boston Scientific as part of the financing
of Boston Scientific’s acquisition of
Guidant. To limit any long-term
entanglements between the parties, the
proposed Consent Agreement requires
Abbott to relinquish its voting rights (by
voting its shares in the same proportion
as all other shareholders in shareholder
votes) and to divest its equity stake in
Boston Scientific within thirty months
of closing.
Implantable Cardioverter Defibrillators
ICDs are small electronic devices
installed inside the chest to prevent
sudden death from cardiac arrest due to
abnormal heart rhythms. They are
designed to counteract fibrillation of the
heart muscle and restore normal heart
rhythms by applying a brief electric
shock. Three firms—Medtronic,
Guidant, and St. Jude Medical—account
for more than 98 percent of the $1.8
billion in annual sales in the U.S. ICD
market, and have been the only
competitively significant providers of
ICDs in the United States for over ten
years. Although Boston Scientific does
not currently sell and is not developing
any ICD products, it owns a ten to
fifteen percent equity stake in a CRM
start-up known as Cameron Healthcare
Inc. More importantly, it has an option
to acquire Cameron that provides
certain information sharing and control
rights prior to the exercise of the option.
Cameron is developing a novel,
‘‘leadless’’ subcutaneous ICD that is on
track to receive FDA approval in
approximately two to three years.
As in the DES, PTCA balloon catheter,
and coronary guidewire markets,
additional entry into the U.S. market for
ICDs is difficult, time-consuming, and
expensive. FDA approval is required to
market ICDs in the United States and a
new entrant would need to navigate
around the substantial intellectual
property barriers that exist in order to
make a significant market impact.
Boston Scientific’s option to acquire
Cameron provides Boston Scientific
with access to non-public information
about Cameron and control over certain
actions of Cameron that were originally
intended to protect Boston Scientific’s
investment. After Boston Scientific is
combined with Guidant, those
previously unobjectionable provisions
may adversely affect competition in the
ICD market because they allow the
combined Boston Scientific/Guidant to
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receive information from and exercise
control over Cameron—a potentially
significant future competitor.
To alleviate these competitive
concerns, the proposed Consent
Agreement imposes limits on Boston
Scientific’s access to Cameron
information and on Boston Scientific’s
ability to exercise any control over
Cameron. First, a firewall will be
established that will limit the
circumstances under which Boston
Scientific will receive Cameron
information, as well as the individuals
at Boston Scientific who may receive
such information. Second, with respect
to the control provisions, Boston
Scientific will relinquish its right to
exercise those provisions unilaterally.
Pursuant to the proposed consent order,
a proxy will be appointed who will
independently determine whether
Boston Scientific may exercise its
contractual control rights. The purpose
of the proxy is to ensure that Boston
Scientific makes decisions with respect
to the control provisions in the same
manner as it would have absent the
Guidant transaction. In making that
determination, the proxy will act as an
ordinary, prudent corporation of the
scope of Boston Scientific (prior to the
acquisition of the Guidant CRM
business).
Finally, with respect to the ten to
fifteen percent equity stake held by
Boston Scientific in Cameron, Boston
Scientific has agreed to provisions
similar to those governing Abbott’s
equity investment in Boston Scientific,
namely that it will vote its shares in the
same proportion as all other
shareholders in any shareholder vote.
Furthermore, Boston Scientific will
divest its equity investment in Cameron
within eighteen months if it does not
acquire control of Cameron prior to the
expiration of its option or if it is
enjoined from acquiring Cameron.
To ensure that the Commission will
have an opportunity to review any
attempt by Boston Scientific to exercise
its option to acquire Cameron, the
proposed Consent Order contains a
prior notice provision committing
Boston Scientific to an H–S–R
framework even if the transaction
otherwise would be non-reportable.
Appointment of an Interim Monitor and
a Divestiture Trustee
The proposed Consent Agreement
contains a provision that allows the
Commission to appoint an interim
monitor to oversee Boston Scientific’s
compliance with all of its obligations
and performance of its responsibilities
pursuant to the Commission’s Decision
and Order. The interim monitor is
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24717
required to file periodic reports with the
Commission to ensure that the
Commission remains informed about
the status of the divestitures, about the
efforts being made to accomplish the
divestitures, and the provision of
services and assistance during the
transition period for the divestiture.
Finally, the proposed Consent
Agreement contains provisions that
allow the Commission to appoint a
divestiture trustee if any or all of the
above remedies are not accomplished
within the time frames established by
the Consent Agreement. The divestiture
trustee may be appointed to accomplish
any and all of the remedies required by
the proposed Consent Agreement that
have not yet been fulfilled upon
expiration of the time period allotted for
each one.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Decision
and Order or to modify its terms in any
way.
By direction of the Commission, with
Commissioner Harbour recused.
Donald S. Clark,
Secretary.
[FR Doc. E6–6226 Filed 4–25–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator;
American Health Information
Community Chronic Care Workgroup
Meeting
ACTION:
Announcement of meeting.
SUMMARY: This notice announces the
fifth meeting of the American Health
Information Community Chronic Care
Workgroup in accordance with the
Federal Advisory Committee Act (Pub.
L. 92–463, 5 U.S.C., App.).
DATES:
May 3, 2006 from 1 p.m. to 5
p.m.
Mary C. Switzer Building
(330 C Street, SW., Washington, DC
20201), Conference Room 4090.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
https://www.hhs.gov/healthit/ahic/
cc_main.html.
The
meeting will be available via Web cast
at https://www.eventcenterlive.com/
cfmx/ec/login/login1.cfm?BID=67.
SUPPLEMENTARY INFORMATION:
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24718
Federal Register / Vol. 71, No. 80 / Wednesday, April 26, 2006 / Notices
Dated: April 13, 2006.
Kelly Cronin,
Director, Office of Programs and
Coordination, Office of the National
Coordinator.
[FR Doc. 06–3918 Filed 4–25–06; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
https://www.hhs.gov/healthit/ahic/
bio_main.html.
The
meeting will be available via Web cast
at https://www.eventcenterlive.com/
cfmx/ec/login/login1.cfm?BID=67.
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator,
American Health Information
Community Electronic Health Records
Workgroup Meeting
ACTION:
Announcement of meeting.
SUMMARY: This notice announces the
fifth meeting of the American Health
Information Community Electronic
Health Records Workgroup in
accordance with the Federal Advisory
Committee Act (Pub. L. 92–463, 5
U.S.C., App.).
DATES: May 2, 2006 from 1 p.m. to 5
p.m.
Dated: April 13, 2006.
Kelly Cronin,
Director, Office of Programs and
Coordination, Office of the National
Coordinator.
[FR Doc. 06–3920 Filed 4–25–06; 8:45 am]
BILLING CODE 4150–24–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator;
American Health Information
Community Consumer Empowerment
Workgroup Meeting
ACTION:
Announcement of meeting.
Mary C. Switzer Building
(330 C Street, SW., Washington, DC
20201), Conference Room 4090.
FOR FURTHER INFORMATION CONTACT:
https://www.hhs.gov/healthit/ahic/
ehr_main.html.
The
meeting will be available via Web cast
at https://www.eventcenterlive.com/
cfmx/ec/login/login1.cfm?BID=67.
SUMMARY: This notice announces the
fifth meeting of the American Health
Information Community Consumer
Empowerment Workgroup in
accordance with the Federal Advisory
Committee Act (Pub. L. No. 92–463, 5
U.S.C., App.)
DATES: May 1, 2006 from 1 p.m. to 5
p.m.
ADDRESSES:
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Dated: April 13, 2006.
Kelly Cronin,
Director, Office of Programs and
Coordination, Office of the National
Coordinator.
[FR Doc. 06–3919 Filed 4–25–06; 8:45 am]
BILLING CODE 4150–24–M
Dated: April 13, 2006.
Kelly Cronin,
Director, Office of Programs and
Coordination, Office of the National
Coordinator.
[FR Doc. 06–3921 Filed 4–25–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator;
American Health Information
Community Biosurveillance
Workgroup Meeting
wwhite on PROD1PC61 with NOTICES
ACTION:
BILLING CODE 4150–24–M
Announcement of meeting.
SUMMARY: This notice announces the
fifth of the American Health Information
Community Biosurveillance Workgroup
in accordance with the Federal
Advisory Committee Act (Pub. L. 92–
463, 5 U.S.C., App.).
DATES: May 4, 2006 from 1 p.m. to 5
p.m.
Mary C. Switzer Building
(330 C Street, SW., Washington, DC
20201), Conference Room 4090.
ADDRESSES:
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16:58 Apr 25, 2006
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Mary C. Switzer Building
(330 C Street, SW., Washington, DC
20201), Conference Room 4090.
FOR FURTHER INFORMATION CONTACT:
https://www.hhs.gov/healthit/ahic/
ce_main.html.
SUPPLEMENTARY INFORMATION: The
meeting will be available via Web cast
at https://www.eventcenterlive.com/
cfmx/ec/login/login1.cfm?BID=67.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Immunization
Practices
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following teleconference.
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Name: Advisory Committee on
Immunization Practices (ACIP).
Time and Date: 2 p.m.–4 p.m., May 4,
2006.
Place: National Immunization Program
(NIP), Atlanta, Georgia. To participate, please
call 1–888–769–8923, pass code 3537839.
Status: Open to the public, limited only by
the availability of telephone ports.
Purpose: The committee is charged with
advising the Director, CDC, on the
appropriate uses of immunizing agents. In
addition, under 42 U.S.C. 1396s, the
committee is mandated to establish and
periodically review and, as appropriate,
revise the list of vaccines for administration
to vaccine-eligible children through the
Vaccines for Children (VFC) program, along
with schedules regarding the appropriate
periodicity, dosage, and contraindications
applicable to the vaccines.
Matters To Be Discussed: Varicella
vaccination policy options.
This notice is being published less than 15
days as provided under 41 CFR 102–3.150(b),
the public health urgency of this agency
business requires that the teleconference be
held prior to the first available date for
publication of this notice in the Federal
Register.
Contact Person for More Information:
Demetria Gardner, Epidemiology and
Surveillance Division, National
Immunization Program, CDC, 1600 Clifton
Road, NE, Mail Stop E–61, Atlanta, Georgia
30333, telephone 404–639–8096, fax 404–
639–8616.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 20, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 06–3987 Filed 4–25–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
Department of Health and
Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of a New System of
Records (SOR).
AGENCY:
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to establish a new
system titled, ‘‘Medicare Health Support
System (MHS), System No. 09–70–
0574.’’ The program is mandated by
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Agencies
[Federal Register Volume 71, Number 80 (Wednesday, April 26, 2006)]
[Notices]
[Pages 24717-24718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3918]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator; American Health Information
Community Chronic Care Workgroup Meeting
ACTION: Announcement of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the fifth meeting of the American Health
Information Community Chronic Care Workgroup in accordance with the
Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
DATES: May 3, 2006 from 1 p.m. to 5 p.m.
ADDRESSES: Mary C. Switzer Building (330 C Street, SW., Washington, DC
20201), Conference Room 4090.
FOR FURTHER INFORMATION CONTACT: https://www.hhs.gov/healthit/ahic/cc_
main.html.
SUPPLEMENTARY INFORMATION: The meeting will be available via Web cast
at https://www.eventcenterlive.com/cfmx/ec/login/login1.cfm?BID=67.
[[Page 24718]]
Dated: April 13, 2006.
Kelly Cronin,
Director, Office of Programs and Coordination, Office of the National
Coordinator.
[FR Doc. 06-3918 Filed 4-25-06; 8:45 am]
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